PEMBROLIZUMAB for Metastatic cervical cancer

Inclusion criteria

• {"criterion_text":"- Inclusion criteria for the observation cohort: Persistent, recurrent, or metastatic cervical cancer commencing treatment or currently treated with a pembrolizumab containing regimen.\n- Inclusion criteria for the early discontinuation cohort: •\tPrevious inclusion in the observation cohort •\tChoice made to stop pembrolizumab for one of the following reasons: o\tConfirmed complete response if they had received at least 8 cycles of 3- weekly pembrolizumab, including at least 9 weeks beyond a CR (consistent with KEYNOTE-826 criteria) OR o\tImmune-related toxicity grade ≥ 3 OR o\tPatient’s preference (e.g. chronic or invalidating grade 1-2 immune-related toxicity) OR o\tConfirmed partial response if they had received at least 8 cycles of 3- weekly pembrolizumab, including at least 9 weeks beyond a PR (timing consistent with KEYNOTE-826 criteria) •\tEligible and willing to discontinue pembrolizumab (with or without discontinuing bevacizumab)"}

Exclusion criteria

• {"criterion_text":"- Malignant other disease other than cervical carcinoma that required active treatment in the past 2 years: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer, or any carcinoma in situ that have undergone potentially curative therapy are not excluded\n- Any condition, in opinion of the investigator, that may hamper compliance to the study procedures.\n- Insufficient proficiency in written and spoken Dutch to understand the study information, complete Dutch language questionnaires, or provide informed consent will be excluded"}

Primary endpoints

• {"endpoint_text":"- PFS: The time from start of first line treatment to the first documented disease progression or death due to any cause, whichever occurs first.","definition_or_measurement_approach":"The time from start of first line treatment to the first documented disease progression or death due to any cause, whichever occurs first (time-to-event PFS)."}

Secondary endpoints

• {"endpoint_text":"- PFS-12 & PFS-24: The proportion of participants that are PFS event-free at 12 and 24 months for the complete cohort; the observation cohort and the discontinuation cohort separately and the different response outcomes (SD/PR/CR).","definition_or_measurement_approach":"Proportion of participants event-free at 12 and 24 months, assessed separately for cohorts and response outcomes."}
• {"endpoint_text":"- The time from start of first line treatment to death due to any cause for the complete cohort and separately for the observation cohort and the discontinuation cohort.","definition_or_measurement_approach":"Overall survival measured as time from start of first-line treatment to death from any cause."}
• {"endpoint_text":"- The ORR is defined as the proportion of patients with CR and PR. This will be assessed for the complete cohort and separately for the observation cohort and the discontinuation cohort","definition_or_measurement_approach":"Objective response rate = proportion of patients with complete response (CR) or partial response (PR), assessed per cohort."}
• {"endpoint_text":"- The DoR is defined as the time from the first documented evidence of CR or PR until the first documented disease progression or death due to any cause, whichever occurs. It will be evaluated for the total cohort and separately for the observation cohort and the discontinuation cohort","definition_or_measurement_approach":"Duration of response measured from first documented CR/PR to progression or death."}
• {"endpoint_text":"- • The percentage of patients of which irAEs led to discontinuation or interruption (≥12 weeks) of treatment during (rechallenge of) PD-1 blockade separately for the observation cohort and discontinuation cohort • The percentage of patients that develop immune-related endocrinopathies separately for the observation cohort and discontinuation cohort","definition_or_measurement_approach":"Proportion of patients with irAEs leading to discontinuation/interruption ≥12 weeks; proportion developing immune-related endocrinopathies, assessed by cohort."}
• {"endpoint_text":"- The change in QoL will be assessed at different time points (according to Table 1.) and will be reported in a descriptive manner","definition_or_measurement_approach":"Quality of life change assessed at multiple time points (per protocol Table 1) and reported descriptively."}

Netherlands

Earliest CTIS Part Ii Submission Date

02-04-2026

Latest Decision Or Authorization Date

11-05-2026

Processing Time Days

39

Number Of Sites

11

Number Of Participants

261

Primary sponsor

Full Name

Universitair Medisch Centrum Groningen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands